Overdosage with carbinoxamine may cause central nervous system depression or stimulation, hallucinations, convulsions, and death. Atropinelike signs and symptoms – dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur.
The treatment of overdosage consists of discontinuation of Pediatex 12 and institution of symptomatic and supportive therapy. Vital signs (including respiration, pulse, blood pressure, and temperature) and EKG should be monitored. Induction of vomiting is not recommended. Activated charcoal should be given and gastric lavage should be considered after ingestion of a potentially life-threatening amount of drug. In the presence of severe anticholinergic effects, physostigmine may be useful. Vasopressors may be used to treat hypotension.
Pediatex 12 is contraindicated in children younger than 2 years of age because deaths have been reported in this age group.
Nursing MothersPediatex 12 is contraindicated in nursing mothers because of the risk of mortality in infants given carbinoxamine-containing products.
HypersensitivityPediatex 12 is contraindicated in patients who are hypersensitive to carbinoxamine maleate or any of the inactive ingredients in Pediatex 12.
Monoamine Oxidase inhibitorsPediatex 12 is contraindicated in patients who are taking monoamine oxidase inhibitors (MAOI).
Use of Pediatex 12 may result in decreased mental alertness with impaired mental or physical abilities.
The most frequent adverse reactions include: sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial
secretions. In clinical use, younger children and older adults may be particularly sensitive to adverse reactions.
The following adverse reactions, listed by body system, have been identified in case reports and during the use of carbinoxamine in observational studies. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat.
Cardiovascular: Hypotension, headache, palpitations, tachycardia, extrasystoles.
Central Nervous System: Fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.
Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, constipation.
Hematologic: Hemolytic anemia, thrombocytopenia, agranulocytosis.
Laboratory: Increase in uric acid levels.
Respiratory: Tightness of chest and wheezing, nasal stuffiness.
Urogenital: Urinary frequency, difficult urination, urinary retention, early menses.
Pediatex 12 Extended-release Oral Suspension is an H1 receptor antagonist indicated for the symptomatic treatment of:
Pediatex 12 after single-dose administration of 16 mg was bioequivalent to the reference carbinoxamine immediate-release oral solution after the administration of two doses of 8 mg six hours apart under fasting conditions. The carbinoxamine mean (SD) peak plasma concentration (Cmax)Â was 28.7 (5.3) ng/mL at 6.7 hours after Pediatex 12 administration. The plasma half-life of carbinoxamine was 17.0 hours. There was no effect of food on the pharmacokinetic parameters.
Pediatex 12 after multiple-dose administration of 16 mg every 12 hours for 8 days was bioequivalent to the reference carbinoxamine immediate-release oral solution after multiple-dose administration of 8 mg every 6 hours. The mean (SD) steady-state Cmax was 72.9 (24.4) ng/mL at 5.6 hours after Pediatex 12 administration. Carbinoxamine mean (SD) minimum plasma concentration at steady-state was 51.8 (20.3) ng/mL.
Included as part of the PRECAUTIONS section.
PRECAUTIONS Pediatric MortalityDeaths have been reported in children less than 2 years of age who were taking carbinoxamine containing drug products; therefore, Pediatex 12 is contraindicated in children younger than 2 years of age.
Activities Requiring Mental AlertnessPediatex 12 may produce marked drowsiness and impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of Pediatex 12. Avoid concurrent use of Karbinal ER with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur.
Concomitant Medical ConditionsPediatex 12 has anticholinergic (atropine-like) properties and, therefore, should be used with caution in patients with: increased intraocular pressure, narrow angle glaucoma, hyperthyroidism, cardiovascular disease, hypertension, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, or pyloroduodenal obstruction.
Allergic Reactions Due To SulfitesPediatex 12 contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in susceptible individuals. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic individuals.
DosingAdvise patients to measure Pediatex 12 with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose.
Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of FertilityNo long-term studies in animals have been performed to determine the possible effects of carbinoxamine on carcinogenesis, mutagenesis, and fertility.
Use In Specific Populations PregnancyPregnancy Category C. Animal reproductive studies have not been conducted with carbinoxamine maleate. It is also not known whether Pediatex 12 can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Pediatex 12 should be given to a pregnant woman only if clearly needed.
Labor And DeliveryThe effect of Pediatex 12 on labor and delivery is not known.
Nursing MotherBecause of the risk of mortality in infants given carbinoxamine-containing drugs, use of Pediatex 12 is contraindicated in nursing mothers.
Pediatric UseDeaths have been reported in children younger than 2 years of age who were taking carbinoxaminecontaining drug products. Therefore, Pediatex 12 is contraindicated in children younger than 2 years of age and in nursing mothers. Carbinoxamine may diminish mental alertness or produce sedation in children. Paradoxical reactions with excitation are more likely in younger children.
Geriatric UsePediatex 12 may cause dizziness, hypotension, confusion, or over-sedation in the elderly. Start elderly patients on lower doses and observe closely.
The dosage of Pediatex 12 should be individualized based on the severity of the condition and the response of the patient. Start with lower doses and increase as needed and tolerated.
Administer Pediatex 12 by the oral route only. Measure Pediatex 12 with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose.
Adults and Adolescents 12 years of age and older:Â 7.5 mL to 20 mL (6 to 16 mg) every 12 hours Children 2 to 11 years of age (approximately 0.2 to 0.4 mg/kg/day):
2 to 3 years: 3.75 mL to 5 mL (3 to 4 mg) every 12 hours
4 to 5 years: 3.75 mL to 10 mL (3 to 8 mg) very 12 hours
6 to 11 years: 7.5 mL to 15 mL (6 to 12 mg) every 12 hours
